Efficacy and Safety of Milrinone Versus Sildenafil in the Treatment of Neonates With Persistent Pulmonary Hypertension (ESMPPHTN)

Rania Ali El-Farrash

Status and phase: Completed; Phase 1

Conditions: Persistent Pulmonary Hypertension

Treatments: Drug: Milrinone; Drug: Sildenafil

Study type: Interventional

Funder types: Other

Identifiers

NCT04391478

NCT 30

Details and patient eligibility

About

Compare the effect of milrinone versus sildenafil in treatment of neonates with persistent pulmonary hypertension.

Full description

40 neonates with PPHN, met inclusion criteria, randomly assigned to 2 groups, each includes 20, first group received intravenous milrinone and second group received nasogastric sildenafil. both groups receive other supportive care.

Enrollment: 40 patients

Sex: All

Ages: 1 hour to 10 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• gestational age >34 weeks
• postnatal age <10 days

Exclusion criteria

• neonates with congenital heart disease
• neonates with congenital diaphragmatic hernia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

milrinone

Active Comparator group

Description:

Milrinone is a phosphodiesterase inhibitor typ3 used in treatment of PPHN. used in dose (0.25 to 0.75 mg/kg/min) intravenous infusion compared with nasogastric sildenafil.

Treatment:

Drug: Milrinone

sildenafil

Active Comparator group

Description:

Sildenafil is a phosphodiesterase inhibitor typ 5 used in treatment of PPHN. used in dose (0.2 to 0.5 mg/kg/6h) by nasogastric tube compared with intravenous milrinone infusion.

Treatment:

Drug: Sildenafil